FDA 483 - RK Pharma Inc. - March 27, 2026

An FDA inspection of Rx Pharma Inc. in Pearl River, NY, revealed significant deficiencies in laboratory controls and investigation procedures for drug product manufacturing. The firm failed to ensure the reliability of its visual inspection process for detecting particulates and critical defects, and its investigations into recurring non-viable particle count excursions and out-of-specification results were inadequate. These issues indicate a potential compromise in drug product quality and purity due to a lack of proper root cause analysis and effective corrective actions.